Parenteral solution equipment



Jan. 24, 1961 5 -K. E. BAUMANN 2,969,158

. PARENTERAL sownou EQUIPMENT Filed March 2. 1959 i Q I ATTORNEYS United States Patent PARENTERAL SOLUTION EQUIPMENT Karl E. Baumann, Mount Prospect, Ill., assignor to Baxter Laboratories, Inc., Morton Grove, Ill., a corporation of Delaware Filed Mar. 2, 1959, Ser. No. 796,366

9 Claims. (Cl. 215-37) This invention relates to parenteral solution equipment and, more particularly, to a container for parenteral solutions and a closure therefor.

- Most commonly, parenteral solutions are stored and dispensed in so-called bulk bottles. These bottles often have an internal volume capable of containing 250 ml., 500 ml., or a liter of such solutions as glucose, saline, etc. Also, the interior of these bottles is maintained under vacuum, the inrush of air when the closure is opened giving the surgeon or nurse a positive indication that the contents have been maintained in a sterile condition. The complete sterility of the solution is mandatory, since these solutions usually are directed into the blood stream of a patient, where any contamination might be dangerous to the patients life.

-.Thus, the principal prerequisite of a closure for a parenteral solution bottle is that it provide a complete barrier against any possibility of contamination. On the other hand, the closure for the parenteral solution bottle must be fairly readily detached, as in many instances it is necessary to administer the solution to the patient with a minimum of delayspeed being imperative in order to maintain the patients fluid balance. Therefore, any closure must provide an extraordinarily effective seal while at the same time being readily removable. In the past, these objectives have been only imperfectly achieved in any given closure. The provision of a closure achieving these desirable objectives is one of the objects of this invention.

Another object is to provide a novel closure for a parenteral solution bottle which is characterized by a plurality of spaced-apart seals guarding against the entry of contamination into the bottle. Still another object is to provide a closure for a parenteral solution bottle, the contents of which are under sub-atmospheric pressure, in which a flexible disc is maintained between'novel closure elements to provide a plurality of seals. Yet another object is to provide a novel closure for a parenteral solution bottle which is eifective in maintaining the bottle contents isolated from the atmosphere during heat sterilization of the bottle.

A further object is to provide a novel closure for a parenteral solution bottle embodying means for quickly removing the closure for access to the bottle contents and in which the removing means is positioned against inadvertent actuation prior to intended use. Other objects and advantages of this invention can be seen as this specification proceeds.

The invention will be explained in conjunction with an illustrative embodiment in the accompanying drawing, in which Fig. 1 is a top plan view of a parenteral solution bottle equipped with a closure embodying teachings of the invention; I

Fig. 2 is a view similar to Fig. 1 but with the outer portion of the closure removed;

- Fig. 3 is a fragmentary vertical sectional view of a parenteral solution bottle equipped with the closure seen in Figs. 1 and 2; and

, Fig. 4 is an exploded, perspective view of the closure seen in the preceding views.

In the illustration given, the numeral 10 designates generally a parenteral solution bottle which usually is constructed of glass and is equipped with the usual neck ending in a lip 12. The outer wall of the bottle in the area of the neck may be equipped with one or more angular beads 13 and which may be employed for securing the closure to the bottle.

The neck 11 of the bottle 10 is closed by a stopper 14 which is equipped with a pair of passages 15 and 16 extending therethrough. Mounted in passage 15 is an air tube 17 which extends downwardly inwardly in the bottle 11 to a point adjacent the bottom thereof.

In the use of the apparatus just described, the bottle- 10 is mounted with its neck positioned downwardly, and an administration set (not shown) is coupled to passage 16. Liquid flowing out of bottle 10 through passage 16 leaves a space in the bottle which is filled by air entering. the bottle 10 through the air tube 17.

The stopper 14 is described in greater detail in the 00- owned, copending application of Robert C. Reimann, Serial No. 814,089 filed May' 18, 1959. The stopper 14,. as can be best seen in Figs. 3 and 4, includes a generally cylindrically-shaped body constructed of a resilient ma-'- terial such as rubber. The passages 15 and 16 extend generally parallel with the axis of the cylindrical body of stopper 14 and communicate the interior of the bot--'- tle 10 with the atmosphere. The stopper 14 is equipped'i with an annular, laterally-extending flange 18 which over-- lies and rests upon the lip 12 of bottle 10. The top sur-- face 19 of stopper 14 is equipped with a centrally de-' pressed portion 20 which, as is best seen in Fig. 3, takes: the form of a frusto-conical depression. The provisiom of the depression 20 results in the provision of a circular" rib 21. The rib 21, which protrudes upwardly from the: top surface 19 of stopper 14, is characterized by a sharp upper edge designated 22 in Fig. 3. The stopper 14 is: also equipped with a notched-out portion 23 (seen only' in Fig. 4) which is located adjacent the bottom of the: stopper 14 and is in general alignment with a line connect-'- ing the centers of the two passages 15 and 16. The cutout portion 23 can be employed as an indexing means for aligning the stopper in a proper orientation for the receipt of air tube 17 where machine assembly is employed.

Completing the closure for the bottle 10 are four elements, best seen in Fig. 4. Immediately overlying the stopper 14 and adjacent the top surface 19 thereof, is a flexible disc 24, which may be constructed of rubber and which has a diameter about that of the perimetric flange 18. The perimetric flange 18 is equipped with a circular, notched-out portion 18a (see Fig. 3) adjacent the top surface 19 of stopper 14, which results in a perimetric portion of the disc 24 being unsupported. Overlying disc 24 and extending downward into locked relation with a bead 13 on bottle 10, is an inner cap 25. The inner cap 25 is essentially cup-shaped in configuration and, in the form seen in Fig. 4, has its side Walls straight and uncrimped. The installation procedure contemplates the rolling of the lip 25:: of inner cap 25 in the manner seen in Fig. 3.

The inner cap 25 is also characterized by having a generally flat face 25b (designated only in Fig. 4) and which is centrally apertured as at 250. The central aperture extends in one wall segment thereof laterally and downwardly to form a cut-out portion 25d. Thus, the peripheral portion of disc 24 is available for finger (grasping through the cooperation of notch 25d and the circular recess 18a.

In order to expose the disc 24 for the purpose of removal thereof, the bottle and its closure being shown in the disc-exposed condition seen in Fig. 2, it is first necessary to remove outer closure elements seen in the upper portion of Fig. 4. These outer closure elements 'include a rigid disc 26, which immediately overlies the inner cap 25, and an outer cap 27 which overlies the metal disc 26. The bottle 19, equipped with its full closure, is seen in Fig. 1.

The outer cap 27, like the inner cap 25, is cup-shaped, with depending side walls that are adapted to be rolled under bead 13 to provide the locking lip designated 27a in Fig. 3. The base, or, in the illustration given, the top Wall 27b of outer cap 27, is substantially fiat and is also centrally apertured as at 270. However, the aperture 270 difiers from the aperture 250 of the inner cap 25 in that the aperture 270 of the outer cap 27 is essentially C-shaped. Such aperturing of the outer cap 27 results in a tab 28 which overlies the disc 26. The top wall 27b of the outer cap 27 is weakened as at 29 and the depending side wall is also weakened as by perforation at 30. The cooperation of the tab 28 with the weakened portions 2? and 30 results in a means for rupturing or severing the outer cap 27, permitting quick removal thereof from over the inner cap 25. The rigid disc 26, being held in place on y by the locking engagement of outer cap 27 with the bead 13, can be also readily removed. Thus, by a simple tab manipulation, the closure seen in Fig. 1 is converted to the closure arrangement seen in Fig. 2, at which time the disc 24 can be lifted off the stopper 14 by grasping a perimetric portion thereof in the manner indicated before. The inner cap 25 is not ruptured, and remains in place on the bottle 10 throughout the dispensing operation and maintains the stopper 14 in place in the neck 11 against any possible dislodgement.

The rigid disc 26, which may be constructed of metal such as aluminum or steel, is centrally depressed as at 31. The shape of the depression 31 is also frusto-coni cal and thereby provides a downwardly and inwardly sloping portion 31a that cooperates with a corresponding downwardly and inwardly-sloping portion 2th: in the top surface 19 of stopper 14 (this being designated only in Fig. 4). This cooperation results in an annular seal 32 (seen only in Fig. 3) between flexible disc 24 and the top surface 19 of stopper 14. Concentric with the seal 32 is a second seal provided by the cooperation of rib 21 with disc 24 urged thereagainst by the flat peripheral portions of inner and outer caps 25 and 27, respectively.

Yet a third seal is provided in the normal use of the bottle 1% closed as shown, through the operation of the sub-atmospheric pressure within the bottle 10. The closure, being under atmospheric pressure, results in portions of flexible disc 24 being drawn in o passages 15 and 16 to cause the dimpling effect designated 15:: and 16a in Fig. 2.

In the assembly of the closure-equipped parenteral solution bottle, the stopper 14 is first equipped with the air tube 17, employing the notched-out portion 23 as a registration means for the machine assembly of these two components. Thereafter, the air tube-equipped stopper 14 is mounted in the neck 11 of the bottle 10 which has been previously suitably charged with a parenteral solution. Thereafter, the disc 24 is positioned over the stopper 14 and against the top surface 19 thereof. At this point, the assembly is introduced into a vacuum-inducing machine which contemporaneously applies the closure elements 25-27. The inner and outer caps 25 and 27, along with the rigid disc 26, can be provided as an assembled unit with the inner cap 25 nested within the outer cap .27. and having disc 26 posion within the central depression 31.

sitioned therebetween. This sub-assembly is provided with the tab 28 depressed below the top surface 271: of outer cap 27 and in the depression 31 of disc 26, as is best seen in" Fig. 3. When the sub-assembly of elements 2527 is applied by the vacuum-inducing machine, it is pressed downwardly against stopper 14, coma pressing the same slightly. Contemporaneously with the application of a vacuum to the top of bottle 10, the depending skirts of the inner and outer caps 25 and 27 are rolled inwardly, as by spinning, to provide the locking lips 25a and 27a seen in Fig. 3. During this operation, the pressure against the caps 25 and 27 is against the perimetric top portions, with the result that the tab 28 is raised slightly from a position of complete depres- This makes for convenient finger grasping of the tab 28 for the tearing operation necessary to remove the outer cap 27.

After the bottle 10 has been equipped with the closure in the manner just described, it is removed to an autoclave, or the like, for heat sterilization. Ordinarily, heat sterilization is achieved by subjecting the bottle to a temperature in the range of 230-250" F. for a period of one-half hour or so. Usually, steam of the order of 12 p.s.i. (g) is introduced into the autoclave to provide the necessary temperature increase. In the initial stages of the heat sterilization, the dimples 15a and 16a become more pronounced, since the exterior of the closure is now under supra-atmospheric pressure, while the interior is still at sub-atmospheric pressure. Thereafter, however, the elevated temperature results in the development of steam within bottle 10, so that the dimples essentially disappear under the equilibrium conditions within and without bottle 10. Thus, there is a pronounced flexing of the disc 24, especially in the central portion thereof. At the conclusion of the heat sterilization step of the cycle, the autoclave is vented, reducing the pressure within the autoclave to atmospheric. However, the steam within bottle'10 condenses more slowly, so that at this point there is a pressure diiferential of reverse character existing across flexible disc 24. This results in a tendency of disc 24 to balloon outwardly, so that the third seal effected between disc 24 and stopper 14- disappears. The third seal is subsequently regained when the contents of bottle 10 return to lower temperatures, with the attendant condensation of the steam to return the botle to its sub-atmospheric pressure. This results in the reappearance of the dimples 15a and 16a which indicate that there is a seal between diaphragm 24 and stopper 14 about the upper ends of passages 15 and 16.

I have found that the provision of the cap subassembly, including elements 25-27, to be effective in maintaining the interior of bottle 10 sealed against contamination during the critical portion of the sterilization cycle, i.e., that portion following the heating step and where the flexible disc or diaphragm 24 has a tendency to balloon outwardly. Although viable organisms would be killed by the temperature, there is always a possibility that inert contaminants such as metal or dirt particles may be drawn into the bottle if the seal between the stopper and disc 24 is not efifective. Complicating the attempt to achieve perfect seals between the disc 24 and the stopper 14 is the presence of the dimples 15a and 16a, which form contemporaneously with the application of the cap subassembly to the bottle 10. The dimples are accompanied by folds in the flexible disc 24, which extend outwardly toward the periphery thereof and which could provide minute channels for the entry of undesirable contaminants. The tendency of the disc 24 to assume this folded condition during the vacuum-inducing and capping operation is effectively opposed by the provision of the central depression 20 in stopper 14 and the central depres sion 31 in disc 26. These depressions and the elements.

having the same cooperate to maintain the disc 24 in a substantially unfolded condition, while concentric seals between the disc 24 and the stopper 14 are provided at 32 and 22. These seals remain in elfect during the heat sterilization operation to guard against entry of contaminants. At the same time, the depression 31 in disc 26 provides a chamber or space for the location of the tab 28, whereby it is maintained substantially below the outer surface 27b of outer cap 27. This avoids any inadvertent or accidental detachment of tab 28 during storage, shipment, or the like, and which would expose the disc 24 prior to the time the solution is intended to be used. In the past, there has been a problem in the storage and handling of bulk parenteral solution bottles, since the tab 28 often is accidentally manipulated prior to the time detachment of the outer cap 27 was indicated. Here, it is to be appreciated that the need for having an easily removable closureto provide the desired speed in operationcomes into conflict with providing a closure of the character that resists any accidental detachment. Here, however, the improved closure provides both of these desirable features. The closure is conveniently and readily removed when necessary, but up to that time is provided in a manner avoiding the possibility of accidental removal. At the same time, the closure provides a superior seal against contamination of the bottom interior and avoids the problems previously experienced with folds being induced in the flexible diaphragm because of the existence of the dimples 15a and 16a.

While, in the foregoing specification, I have set forth a detailed description of an embodiment of the inven tion for the purpose of explanation thereof, it will be apparent to those skilled in the art that many variations may be made in the details thereof without departing from the spirit and scope of the invention.

1 claim:

1. In a closure for a parenteral solution bottle having its interior under a pressure of less than atmospheric and equipped with a neck, a resilient plug mounted in the bottle neck and closing the same, said plug having a pair of passages extending therethrough communicating the bottle interior with the atmosphere, said plug having an annular flange adjacent its outer end overlying the bottle top, said plug having an integral circular rib on its outer end about said passages to provide a central depressed portion, a resilient disc overlying said outer end of said plug, a rigid, cup-shaped cap anchored to said bottle neck and overlying said disc, said cap comprising a pair of nested cup-shaped members, each of the members being equipped with a central aperture in the cup face, a rigid disc interposed between said members and closing said apertures, said rigid disc having a centrally depressed portion aligned with the plug depressed portion.

2. The structure of claim 1 in which the outer of said cup-shaped members is equipped with tab means effective to rupture the wall of said outer member and permit removal thereof from said bottle, said tab means extending into the central aperture of said outer member and being positioned beneath the surface of said outer member and adjacent and within the depressed portion of said disc.

3. In a closure for a parenteral solution bottle, a resilient plug having a generally frusto-conical depression in the upper end thereof and a pair of passages extending therethrough from the upper end thereof, a rigid cupshaped cap overlying said plug and enclosing the same for securing said plug in the bottle neck, said cap having a generally frusto-conical, inwardly-extending depression in the base thereof aligned with the plug depression, and a flexible diaphragm clamped between said cap and plug and covering said passages, said cap being equipped with cap wall-rupturing tab means positioned within said cap depression.

4. The structure of claim 3 in which said cap comprises a pair of nested cup-shaped members, the inner of said members having a central aperture in the base thereof, the outer of said members having a C-shaped aperture in the base thereof to provide integral tab means opera tive to rupture the wall of said outer member, and a rigid disc between the bases of said members, said disc being equipped with a frusto-conical depression in which said tab means is positioned.

5. The structure of claim 4 in which each of said members in the bases thereof outward of the aperture therein, and the disc outward of said depression, are substantially flat.

6. In a cap closure for a parenteral solution bottle closed by a resilient stopper having a central depression in the stopper top, a metal cup-shaped body having a central depression in the base thereof alignable with the stopper depression, and tab means positioned in said body depression externally thereof for rupturing a portion of said body and exposing said stopper.

7. In a closure for a parenteral solution bottle having its interior under a pressure of less than atmospheric and equipped with a neck, a resilient stopper having a central depression in said stopper top, a rigid cup-shaped cap overlying said stopper and enclosing the same for securing said plug in the bottle neck, and a flexible diaphragm clamped between said plug and cap, said cap having a central depressed portion removably attached to said cap and effective to urge said diaphragm into sealing relation with said stopper top.

8. In a cap closure for a parenteral solution bottle closed by a resilient stopper having a central depression in the stopper top, a rigid cup-shaped body having a central depression in the base thereof alignable with the stopper depression and tab means positioned upon the external surface of said body for rupturing a portion thereof and exposing said stopper.

9. In a closure for a parenteral solution bottle, a resilient plug having a generally frusto-conical depression in the upper end thereof and a pair of passages extending therethrough from the upper end thereof, a rigid cupshaped cap overlying said plug and enclosing the same for securing said plug in the bottle neck, said cap having a generally frusto-conica-l, inwardly-extending depression in the base thereof alignable with the plug depression, and a flexible diaphragm clamped between said cap and plug and covering said passages, said cap having tab means for rupturing said cap walls to allow removal of the said flexible diaphragm.

References Cited in the file of this patent UNITED STATES PATENTS 663,616 Smelker Dec. 11, 1900 1,595,177 Winters Aug. 10, 1956 

